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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K140522
Device Name RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL
Applicant
RANDOX LABORATORIES LIMITED
55 DIAMOND RD.
CRUMLIN, CO.ANTRIM,  GB BT29 4QY
Applicant Contact PAULINE ARMSTRONG
Correspondent
RANDOX LABORATORIES LIMITED
55 DIAMOND RD.
CRUMLIN, CO.ANTRIM,  GB BT29 4QY
Correspondent Contact PAULINE ARMSTRONG
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/04/2014
Decision Date 05/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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